Mild Cognitive Impairment, Stroke
Conditions
Keywords
Post-Stroke cognitive impairment
Brief summary
This study will evaluate the effects of a form of non-invasive brain stimulation on brain functioning and memory in participants with post-stroke cognitive impairment (PSCI).
Detailed description
The goal of this study is to learn important information about the effects of electrical stimulation (Transcranial direct current stimulation (tDCS) on brain functioning in those with post-stroke cognitive impairment (PSCI). The findings will help determine how stimulation affects the brain's activity, cerebral blood flow, and circulating blood biomarkers of neuroinflammation after stroke. The study will use different forms of non-invasive brain imaging to see whether stimulation changes how the brain responds during a memory task. Functional near-infrared spectroscopy (fNIRS) and electroencephalograph (EEG) will be used, we will also collect blood samples for the biomarkers of inflammation. The study also uses cognitive tests and questionnaires.
Interventions
tDCS will deliver direct current through rubber electrodes in saline-soaked sponges. Device sends a low-level current from the positive electrode, the anode, to the negative electrode, the cathode. Direct current will be transferred by a saline-soaked pair of surface sponge electrodes (35cm2) and delivered by a specially developed, battery-driven, constant current stimulator with a maximum output of 10mA. The anode will be placed over the LDLPFC and the cathode over the contralateral supra-orbital area.
Sponsors
American Heart Association
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1\) ischemic stroke participants in sub-acute phase (at least 10 days after stroke event or discharge and under 5 months post-event) with cognitive dysfunction (MoCA \<26);
Exclusion criteria
1. clinically significant or unstable medical or psychiatric condition; 2. diagnosis of severe depression; 3. history of relevant neurological diagnosis (e.g., epilepsy); 4. previous neurosurgical procedure with craniectomy; 5. contraindications to tDCS (implanted brain medical devices); 6. severe visual impairment, hearing impairment, aphasia, neglect or dementia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) | Changes from baseline after intervention week (two weeks), one and three months | It is a 30-point test about several cognitive domains (visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation) and a screening tool used of MCI and dementia. |
| NIH Toolbox | Changes from baseline after one and three months | NIH Toolbox tests is a computarize test that acess fluid abilities (i.e., working memory, processing speed, episodic memory, and two aspects of executive functioning) and crystallized abilities (i.e., dependent upon past learning and experience), resulting in Standard Scores for these superordinate categories, as well as a total Composite score of all tests.These norms were previously reported to align with the age-corrected normative data for the traditional neuropsychological measures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurovascular Coupling - Cerebral blood flow (fNIRS) | Changes on fNIRS signal from baseline after after intervention week (two weeks), one and three months | fNIRS signal will be recorded using the 16-source/16-detector system (NIRSport, NIRx) |
| Brain Function (EEG) | Changes on EEG signal from baseline after after intervention week (two weeks), one and three months | EEG signal will be recorded at 1 kHz using a 16-channel system (HIAMP,g.tec). |
| Neurovascular Coupling - (DVA) | Changes on maximal arteriolar dilation and mean maximal venular dilation from baseline after intervention week (two weeks), one and three months | DVA signal ill be recorded as the mean maximal arteriolar dilation and mean maximal venular dilation in response to flicker light stimulation. |
| Blood markers | Changes on blood marker levels from baseline after intervention week (two weeks), one and three months | Bblood draw via venipuncture and collect up to 40mL of blood for each visit. We will separate set of plasma (for study 4), serum samples, whole blood, and blood cells (including white blood cells) , a set of each will be stored for future analyses. |
Countries
United States
Contacts
Primary ContactCheryl Adams, RN
Backup ContactCamila Bonin Pinto, PhD
Outcome results
None listed